1.3dMD photogrammetric system study of thoracic deformation after multi-rib autologous rib cartilage transplantation for auricle reconstruction
Shuang WANG ; Leren HE ; Hengyuan MA ; Binghang LI ; Dongwen JIANG ; Chenhao MA
Chinese Journal of Plastic Surgery 2024;40(10):1080-1085
Objective:To analyze the characteristics of postoperative thoracic deformation in patients who underwent multi-rib autologous rib cartilage transplantation auricle reconstruction based on 3dMD imaging system.Methods:A retrospective study was conducted using 3dMD data of the thorax from patients who underwent auricle reconstruction surgery using multiple autologous costal cartilages at the First Department of Ear Reconstruction of the Plastic Surgery Hospital, Chinese Academy of Medical Sciences, from July to September 2019. The normal-side chest wall image was superimposed on the rib-harvested side chest wall for automatic registration and alignment, with distance numerical data presented in a Cartesian heat map through color mapping technology. By observing the areas where the rib-harvested side thorax had obvious deformation, the distance difference of the concave and convex peaks on the sagittal diameter was measured to judge the degree of thoracic deformation in children (≤10 mm as none; >10-20 mm as mild; >20-30 mm as moderate; >30 mm as severe).Results:A total of 42 children were included, with 27 males and 15 females, aged from 7 to 12 years old. The Cartesian heat map of thoracic deformation showed that the obvious concave area of the chest wall was located at the junction of the middle and inner one-third of the clavicle and the 7th rib, and the obvious convex area was located in the area from the nipple to the 5th rib. The measurement range of the protrusion peak in the upper chest nipple area was from -7.638 9 to -14.288 4 mm; the measurement range of the depression peak in the rib arch area was from 7.238 7 to 14.653 2 mm. The range of the distance difference between the concave and convex peaks was from 14.877 6 to 28.941 6 mm.The degree and incidence of thoracic deformation in children: mild in 5 cases; moderate in 37 cases.Conclusion:Based on the analysis with 3dMD photogrammetry, the overall characteristics of chest wall deformation in patients who underwent ear reconstruction with autologous rib cartilage grafts were the coexistence of protrusion in the upper chest nipple area and depression in the area where the rib cartilage was harvested, with changes occurring on the sagittal diameter.
2.A systematic review of the current nomenclature and classification of congenital auricular malformations
Wenkang LUAN ; Shujun FAN ; Dongwen JIANG ; Chenhao MA ; Leren HE
Chinese Journal of Plastic Surgery 2024;40(10):1127-1136
The nomenclature of congenital auricular malformations is complex and confusing, which brings great inconvenience to clinical work and scientific research. This study comprehensively summarized and sorted out the existing Chinese and English names of congenital auricular malformations, providing reference basis for the scientific classification and clinical treatment of congenital auricular malformations. Sixty-seven papers on the topic of congenital auricle malformations were collected from databases such as CNKI, Wanfang Database, VIP Database, PubMed, Web of Science, and ScienceDirect by using the PRISMA method. The two core issues of morphological and anatomical naming and classification of congenital auricle malformations were sorted and summarized based on these articles. In this study, the existing Chinese and English names of congenital auricular malformations were summarized, and a preliminary classification was made at the morphological and anatomical levels, and the embryological origin of the external auricle and its substructures was elaborated. Based on the result of this study, a comprehensive analysis can be conducted on the malformations of the ear structures and their embryological origins in order to explore the etiology of congenital ear malformations. It is expected that scientific and standardized naming and classification method can be developed, and reasonable and effective standardized treatment can be formulated for congenital auricular malformations based on this study.
3.The efficacy and impact on quality of life in the elderly patients with proximal ureteral stones larger than 1 cm who reciveing minimally invasive percutaneous nephrolithotomy and retrograde intrarenal surgery
Yanjie MA ; Wei ZHANG ; Changjian ZHAO ; Dongwen WANG ; Lijuan REN
Chinese Journal of Geriatrics 2024;43(8):1007-1012
Objective:To compare the efficacy and impact on the quality of life of elderly patients of minimally invasive percutaneous nephrolithotomy(MPCNL)and retrograde intrarenal surgery(RIRS)in the treatment of unilateral upper ureteral calculi larger than 1.0 cm in diameter.Methods:A total of 104 patients were prospectively collected from January 2021 to December 2022 in the First Hospital of Shanxi Medical University.Based on the inclusion and exclusion criteria, 88 patients were finally included, 32 patients in the MPCNL group and 56 patients in the RIRS group, and the independent samples t-test, χ2 test, or Fisher's exact probability method were used to compare the differences in the general information, stone characteristics, and intraoperative and postoperative indexes between the two groups, and the quality-of-life scores were applied with the SF-36 Health Survey form. Results:There were no significant differences in age[(67.52±7.41)years and(67.38±7.25)years], gender[male/female: 19/13 cases and 36/20 cases], body mass index[(23.74±2.93)kg/m 2 and(23.70±2.57)], stone location(left/right: 20/12 cases and 38/18 cases), degree of hydronephrosis(mild/moderate/severe: 9/20/3 cases and 16/38/2 cases), stone maximum diameter[(14.12±3.69)mm and(13.34±2.99)mm], stone CT values[(1 035.7±275.7)HU and(973.3±253.8)HU]and postoperative complications[15.6%(5/32)and 14.3%(8/56)]between the two groups of patients( P>0.05).However, there were significant difference in stone clearance rate[96.9%(31/32) vs.80.4%(45/56)], and the operation time[(44.44±9.91)min vs.(54.69±11.94)min]between the two groups.The hospital stay in the RIRS group was shorter than that in the MPCNL group[(5.27±2.27)d vs.(8.00±2.19)d, P<0.05].There was no significant difference in the scores of eight dimensions between the two groups before surgery( P<0.05).At the day of discharge, patients in the MPCNL group had significantly lower mean scores than the RIRS group on six different subscales of the SF-36 questionnaire, namely, physical functioning, role-physical, bodily pain, social functioning, role-emotional and mental health.No differences in the mean scores for general health and vitality between the two groups were noted.In terms of SF-36 scores at one month after operation, the MPCNL group had lower scores in physical pain and social function than the RIRS group and the difference was statistically significant( P<0.05).No differences in the mean scores for other domains at one month after operation between patients undergoing MPCNL and those undergoing RIRS were noted. Conclusions:For patients with unilateral upper ureteral calculi larger than 1.0 cm in diameter, MPCNL has higher stone-free rate and shorter operation time than RIRS, but longer hospitalization time, and MPCNL has a greater impact on the quality of life of patients with ureteral calculi than RIRS in many aspects.
4.3dMD photogrammetric system study of thoracic deformation after multi-rib autologous rib cartilage transplantation for auricle reconstruction
Shuang WANG ; Leren HE ; Hengyuan MA ; Binghang LI ; Dongwen JIANG ; Chenhao MA
Chinese Journal of Plastic Surgery 2024;40(10):1080-1085
Objective:To analyze the characteristics of postoperative thoracic deformation in patients who underwent multi-rib autologous rib cartilage transplantation auricle reconstruction based on 3dMD imaging system.Methods:A retrospective study was conducted using 3dMD data of the thorax from patients who underwent auricle reconstruction surgery using multiple autologous costal cartilages at the First Department of Ear Reconstruction of the Plastic Surgery Hospital, Chinese Academy of Medical Sciences, from July to September 2019. The normal-side chest wall image was superimposed on the rib-harvested side chest wall for automatic registration and alignment, with distance numerical data presented in a Cartesian heat map through color mapping technology. By observing the areas where the rib-harvested side thorax had obvious deformation, the distance difference of the concave and convex peaks on the sagittal diameter was measured to judge the degree of thoracic deformation in children (≤10 mm as none; >10-20 mm as mild; >20-30 mm as moderate; >30 mm as severe).Results:A total of 42 children were included, with 27 males and 15 females, aged from 7 to 12 years old. The Cartesian heat map of thoracic deformation showed that the obvious concave area of the chest wall was located at the junction of the middle and inner one-third of the clavicle and the 7th rib, and the obvious convex area was located in the area from the nipple to the 5th rib. The measurement range of the protrusion peak in the upper chest nipple area was from -7.638 9 to -14.288 4 mm; the measurement range of the depression peak in the rib arch area was from 7.238 7 to 14.653 2 mm. The range of the distance difference between the concave and convex peaks was from 14.877 6 to 28.941 6 mm.The degree and incidence of thoracic deformation in children: mild in 5 cases; moderate in 37 cases.Conclusion:Based on the analysis with 3dMD photogrammetry, the overall characteristics of chest wall deformation in patients who underwent ear reconstruction with autologous rib cartilage grafts were the coexistence of protrusion in the upper chest nipple area and depression in the area where the rib cartilage was harvested, with changes occurring on the sagittal diameter.
5.A systematic review of the current nomenclature and classification of congenital auricular malformations
Wenkang LUAN ; Shujun FAN ; Dongwen JIANG ; Chenhao MA ; Leren HE
Chinese Journal of Plastic Surgery 2024;40(10):1127-1136
The nomenclature of congenital auricular malformations is complex and confusing, which brings great inconvenience to clinical work and scientific research. This study comprehensively summarized and sorted out the existing Chinese and English names of congenital auricular malformations, providing reference basis for the scientific classification and clinical treatment of congenital auricular malformations. Sixty-seven papers on the topic of congenital auricle malformations were collected from databases such as CNKI, Wanfang Database, VIP Database, PubMed, Web of Science, and ScienceDirect by using the PRISMA method. The two core issues of morphological and anatomical naming and classification of congenital auricle malformations were sorted and summarized based on these articles. In this study, the existing Chinese and English names of congenital auricular malformations were summarized, and a preliminary classification was made at the morphological and anatomical levels, and the embryological origin of the external auricle and its substructures was elaborated. Based on the result of this study, a comprehensive analysis can be conducted on the malformations of the ear structures and their embryological origins in order to explore the etiology of congenital ear malformations. It is expected that scientific and standardized naming and classification method can be developed, and reasonable and effective standardized treatment can be formulated for congenital auricular malformations based on this study.
6.Aldehyde dehydrogenase 2 gene polymorphism and its correlation with the occurrence of type 2 diabetes mellitus and coronary stenosis in the elderly: a retrospective study
Guoqiang CAI ; Dongwen MA ; Juan XU ; Tong XU ; Xinmei LIU
Journal of Chinese Physician 2023;25(10):1530-1533
Objective:To investigate the allele distribution of aldehyde dehydrogenase 2 (ALDH2) gene polymorphism in elderly patients with type 2 diabetes mellitus (T2DM) and to analyze its correlation with the presence and severity of coronary stenosis.Methods:A total of 94 elderly patients with T2DM who were admitted to the Affiliated Hospital of Jining Medical University from March 2020 to March 2022 were selected as the observation group, and 50 age- gender-matched healthy subjects were selected as the control group. The observation group was further divided into stenosis group and non-stenosis group based on the presence of coronary stenosis. Clinical data were collected from all participants, and blood samples were taken for analysis. The ALDH2 gene polymorphism (rs671 locus) was detected using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) technology. The distribution of ALDH2 genotypes was observed in elderly patients with T2DM, and multivariate logistic regression analysis was used to identify independent factors associated with the development of coronary stenosis in elderly patients with T2DM. The degree of coronary stenosis was compared between patients with different genotypes.Results:The allele A frequency of ALDH2 gene (rs671 locus) was significantly higher in the observation group than in the control group ( P<0.05). The proportion of patients with diabetes duration≥5 years and smoking history in the stenosis group was significantly higher than that in the non-stenosis group (all P<0.05). Serum levels of glucose (GLU), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) were significantly higher in the stenosis group than in the non-stenosis group, while high-density lipoprotein cholesterol (HDL-C) level was significantly lower in the stenosis group than in the non-stenosis group (all P<0.05). The proportion of ALDH2 genotypes AA and allele A frequency were significantly higher in the stenosis group than in the non-stenosis group (all P<0.05). Long duration of diabetes, low HDL-C level, and ALDH2 genotypes AA were independent risk factors for the development of coronary stenosis in elderly patients with T2DM (all P<0.05). The proportion of patients with three or more coronary artery lesions in the stenosis group with genotype AA was significantly higher than that in the stenosis group with genotypes GG and GA (all P<0.05). Conclusions:ALDH2 gene polymorphism is associated with the development of T2DM in elderly patients, and allele A carriers may have a higher risk of developing coronary stenosis and more severe disease severity.
7.Correlation between the changes of TC, CRP, VEGF after thoracic endovascular aortic repair and the degree of false lumen thrombosis and its clinical significance
Dongwen MA ; Rui ZHANG ; Guoqiang CAI ; Yongliang ZHAO
Journal of Chinese Physician 2022;24(9):1373-1378
Objective:To explore the relationship between the changes of total cholesterol (TC), C-reactive protein (CRP), vascular endothelial growth factor (VEGF) and the degree of false lumen thrombosis after thoracic endovascular aortic repair (TEVAR) and its clinical significance.Methods:A total of 95 patients with aortic dissection admitted to the Affiliated Hospital of Jining Medical College from June 2015 to July 2020 were selected for retrospective study. All patients were treated with TEVAR. According to the disappearance of false lumen detected by computed tomography (CT) angiography six months after operation, 95 patients were divided into complete disappearance group ( n=43) and incomplete disappearance group ( n=52). The levels of plasma TC, CRP and VEGF in the two groups were compared before operation and 1 and 3 months after operation, as well as the degree of false lumen thrombosis. Spearman′s method was used to analyze the relationship between the levels of plasma TC, CRP and VEGF and the degree of postoperative false lumen thrombosis; multivariate logistic regression was used to analyze the factors affecting the disappearance of false lumen after TEVAR; The receiver operating characteristic (ROC) curve and area under the curve (AUC) were used to analyze the value of each index in predicting the complete disappearance of false lumen. Results:The plasma levels of TC, CRP and VEGF in the complete disappearance group were lower than those in the incomplete disappearance group 1 and 3 months after operation (all P<0.05). The degree of false lumen thrombosis in the complete disappearance group was significantly different from that in the incomplete disappearance group 1 and 3 months after operation (all P<0.05). The plasma levels of TC, CRP and VEGF 1 and 3 months after TEVAR were negatively correlated with the degree of false lumen thrombosis (all P<0.05). Multivariate logistic regression analysis showed that the plasma levels of TC, CRP and VEGF 1 and 3 months after operation were correlated with the disappearance of false lumen (all P<0.05). With the passage of time, the AUC of each index to predict the complete disappearance of false lumen gradually increased. At 3 months after operation, the AUC of TC, CRP, VEGF and combined prediction of the complete disappearance of false lumen were 0.706, 0.899, 0.781 and 0.943, respectively (all P<0.05). Conclusions:The changes of plasma TC, CRP and VEGF levels after TEVAR are related to the degree of false lumen thrombosis and the disappearance of false lumen in patients with aortic dissection. Combined examination of the three can be an effective method to predict the complete disappearance of false lumen.
8.Efficacy and safety study of Chinese botulinum toxin A 100U in patients with overactive bladder: a prospective, multicenter, double-blind and randomized controlled trial
Limin LIAO ; Huiling CONG ; Zhihui XU ; Enhui LI ; Zhiliang WENG ; Haihong JIANG ; Ben LIU ; Xiao HUANG ; Shujie XIA ; Wei WEN ; Juan WU ; Guowei SHI ; Yang WANG ; Peijun LI ; Yang YU ; Zujun FANG ; Jie ZHENG ; Ye TIAN ; Haodong SHANG ; Hanzhong LI ; Zhongming HUANG ; Liqun ZHOU ; Yunxiang XIAO ; Yaoguang ZHANG ; Jianlong WANG ; Xiaodong ZHANG ; Peng ZHANG ; Dongwen WANG ; Xuhui ZHANG ; Keji XIE ; Bin WANG ; Lulin MA ; Xiaojun TIAN ; Lijun CHEN ; Jinkai DONG
Chinese Journal of Urology 2021;42(6):414-422
Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.
9.The efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation: a randomized, controlled, multi-center clinical trial with 2 years’ follow-up
Hao YU ; Kaiwen LI ; Hailong HU ; Xiang LI ; Nan LIU ; Jian ZHANG ; Xudong YAO ; Xiaodong ZHANG ; Wei LI ; Liqun ZHOU ; Xiangbo KONG ; Jinjian YANG ; Youhan CAO ; Junli WEI ; Jiacun CHEN ; Zhaoyang WU ; Dongwen WANG ; Xuhui ZHANG ; Jinkai SHAO ; Qingwen LI ; Huiqing ZHANG ; Xiaolin WANG ; Shaozhong WEI ; Ye TIAN ; Tie ZHONG ; Hongshun MA ; Kun LI ; Benkang SHI ; Jin YANG ; Yuhua QIAO ; Hongxing HUANG ; Liming LI ; Zhimin WANG ; Jianhua TIAN ; Tianxin LIN ; Jian HUANG
Chinese Journal of Urology 2020;41(10):724-730
Objective:To investigate the 2 years’ efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation.Methods:From July 2015 to June 2020, 18-75 years old patients with moderate to high-risk non muscle invasive bladder cancer (NMIBC) confirmed by pathological examination were involved. The ECOG score was 0-2. Exclusion criteria included ①immune deficiency or impairment (such as AIDS), using immunosuppressive drugs or radiotherapy, suspected allergic to BCG or epirubicin or excipients of the two drugs, fever or acute infectious diseases including active tuberculosis or receiving anti tuberculosis treatment, with severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; ②combined with other urogenital system tumors or other organ tumors; ③combined with muscle invasive bladder urothelial carcinoma (≥T 2); ④undergoing chemotherapy, radiotherapy or immunotherapy within 4 weeks (immediate instillation after surgery not included); ⑤ pregnant or lactating women; ⑥ comfirmed or suspected bladder perforation; ⑦gross hematuria; ⑧cystitis with severe bladder irritation that may affect the evaluation; ⑨participat in other clinical trials within 3 months; ⑩alcohol or drug addiction; ?any risk factors that may increasing the risk of patients. Epirubicin 50 mg was irrigated immediately after the operation(TURBT or laser resection). The patients were randomly divided into BCG15 group, BCG19 group and epirubicin group by the ratio of 2∶2∶1, and the patients were maintained intravescical instillation for 1 year. The recurrence and adverse events of the three groups were compared. Univariate and multivariate analysis was performed to predict the risk factors of BCG irrigated therapy failure. Result:By June 15, 2020, the median follow-up duration was 22.1 months(12.1, 32.3), and there was no statistical difference between the groups ( P=0.9024). There were 274 patients enrolled in BCG19 group, 277 patients enrolled in BCG15 group and 130 patients enrolled in the epirubicin group. The drop-off rate was 16.6%(113 cases)and made no difference between groups( P=0.6222). There were no significant difference in age, gender, BMI, or ECOG score( P>0.05). During the follow-up, 116 cases was detected recurrence or progression. The recurrence rate of the three groups was 14.2% and 14.8% in BCG19 group and BCG15 group, and 27.7% in the epirubicin group. There was no difference in recurrence rate between BCG19 and BCG15 group( P=0.9464). The recurrence rate of BCG19 group was lower than that of the epirubicin group ( P=0.0017). The recurrence rate of BCG15 group was lower than that of the epirubicin group ( P=0.0020). There was no difference in the cumulative recurrence free survival rate between BCG19 and BCG15 group (95% CI0.57-1.46, P=0.7173). The cumulative recurrence free survival rate of BCG 19 group was better than that of the epirubicin group( HR=0.439, 95% CI0.26-0.74, P=0.0006), and the cumulative recurrence free survival rate of BCG15 group was better than that of the epirubicin group ( HR=0.448, 95% CI0.29-0.80, P=0.0021). The total incidence of adverse events in 19 BCG19, BCG15 and epirubicin group were 74.5%, 72.6% and 69.8% respectively. There was no difference in the incidence of adverse events between BCG19 and BCG15 group( P=0.6153). The incidence of adverse events in epirubicin group was lower than that of BCG19( P=0.0051) and BCG15( P=0.0167) groups.There was no significant difference in the incidence of serious adverse events (SAE) among the three groups ( P=0.5064). Log rank test univariate analysis and Cox risk regression model multivariate analysis showed that the history of bladder cancer recurrence( HR=6.397, 95% CI1.95-20.94, P=0.0001)was independent risk factor for BCG irrigation failure. Conclusions:The 2 years’ efficacy of intravesical instillation of domestic BCG is better than than of epirubicin with good tolerance and safety. There is no difference between BCG19 and BCG15 group. BCG doesn’t increase SAE compared with epirubicin. Recurrence status was an independent prognostic factor regarding recurrence-free survival.
10.The sentinel lymph node biopsy in penile carcinoma guided by multispectral separate-merge guided surgery device
Xiaofeng YANG ; Rui ZHANG ; Xuezhi LIANG ; Xiaoming CAO ; Yanjie MA ; Jingqi WANG ; Yazhou XUE ; Dongwen WANG
Chinese Journal of Urology 2018;39(12):930-934
Objective To explore the method and clinical value of sentinel lymph node biopsy for penile carcinoma guided by multispectral separate-merge guided surgery device (MGS).Methods The clinical data of 7 patients with sentinel lymph node biopsy of penile cancer guided by MGS from April 2017 to April 2018 were analyzed retrospectively at First Hospital of Shanxi Medical University.They were 62-78 years old,with an average age of 65 years.All of carcinoma was located in the glans or coronal sulcus,which diameter was 1.0-3.5 cm,with an average of 2.5 cm.Three cases of inguinal lymph nodes could be non-palpable and the others palpable.All patients were injected 0.25 ml (2.5 mg/ml) of indocyanine greensolution with 1 ml syringe at 12,4,6 and 9 points in the proximal normal skin of penile tumors.Immediately,the imaging probe was aligned with the injection point to observe the dynamic changes of fluorescence image on MGS display.Results There were 14 sides of groin in 7 patients,except for 1 side without images,other 13 sides developed well.The images displayed by MGS include visible image,fluorescent image and merged image,and the merged image was green pseudo color.According to the dynamic changes of the image,it could be divided into five parts:injection point,penile body,pubic symphysis,inguinal region and sentinel lymph node.In 13 well-developed sides,fluorescence gradually disappeared in other parts about 15 minutes after injection,and the location of sentinel lymph nodes was determined in vitro by gradually consolidating and fixing the fluorescence images in the inguinal region.The lymph node-like tissue with strong fluorescence intensity was observed immediately after the skin incision.There was a clear boundary between the lymph node-like tissue and the surrounding tissue.Along this boundary,lymph nodes were separated,ligated,excised.No lymph nodes were found on the undetected side.Postoperative pathology confirmed that lymph nodes were located by fluorescence imaging in vitro and traced by fluorescence imaging in vivo,the coincidence rate was 100%.There were residual fluorescent tissues on three sides and lymphatic vessels were removed.Conclusions MGS-assisted intraoperative fluorescence imaging could improve the doctor's visual depth so that physicians can real-time,dynamic,accurate in vitro location and in vivo tracking of sentinel lymph nodes of penile cancer.

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